WHO has recently revised its guidance on essential medicines adding 12 ground-breaking medicines for five cancer therapies to treat melanoma, lung, blood and prostate cancers.
New medicines to treat cancer and cardiac diseases along with antibiotics may soon be part of the National List of Essential Medicines (NLEM), which forms the basis for price regulation in India.
Taking cue from the World Health Organisation’s (WHO) revised list of essential medicines, the government’s Standing National Committee on Medicines has called for a stakeholder consultation on Thursday to discuss revision of NLEM 2015. Representatives from the pharmaceutical companies, industry associations as well as civil society are expected to attend the meeting.
WHO has recently revised its guidance on essential medicines adding 12 ground-breaking medicines for five cancer therapies to treat melanoma, lung, blood and prostate cancers. It has also added new oral anticoagulants to prevent stroke.
Besides, the UN agency has strengthened its advice on antibiotic use by indicating which antibiotics to use for the most common and serious infections to achieve better treatment outcomes and reduce the risk of antimicrobial resistance. It has recommended three new antibiotics for the treatment of multi-drug resistant infections be added as essential.
The idea behind the stakeholder consultation is to evaluate the WHO list in the Indian context by determining the “essentiality” and “affordability” factors of these medicines.
“The committee will have to grapple with several critical issues including how closely India chooses to follow the WHO list on addition of highly priced cancer drugs, expansion of the list to add more medical devices and contextualizing WHO recommendations on classifying antibiotics keeping in mind local regulations and access frameworks,” said public health expert Malini Aisola of All India Drug Action Network (AIDAN).
Currently, there are around 376 medicine formulations which are part of the NLEM. These medicines, deemed essential for the treatment of common conditions, automatically come under price control.
In addition, the government has the power to bring any item of medical necessity under price control under Para 19 of the Drug Price Control Order, 2013.
Earlier this year, the government used this provision to cap trade margins of 42 cancer drugs at 30% expanding the span of price control to curtail undue profiteering by chemists and drug stockists on various medicines which were so far outside price regulation.
Over 150 countries use WHO’s Essential Medicines List to guide decisions about which medicines represent the best value for money, based on evidence and health impact. Even India’s NLEM is primarily guided by the UN agency’s list which prioritizes critical health products that should be widely available and affordable throughout health systems.
However, the pharmaceutical industry is concerned that the government must not look at adopting the WHO list at it without evaluating it strategically.
“We hope the government will look at it from essentiality and accessibility point of view and not bring these drugs under price control. If they do so, then all strengths must not be added for formulations added to the list,” an industry executive said.